Australian National Vulvar Cancer Trial

Launched by QUEENSLAND CENTRE FOR GYNAECOLOGICAL CANCER · Jun 23, 2024

Keywords

ClinConnect Summary

The Australian National Vulvar Cancer Trial is a study designed to explore a new way to monitor and manage vulvar cancer in women. Specifically, it aims to see if using intensive ultrasound to watch the groin area can safely replace a more invasive surgery called lymph node dissection. This trial will help determine if this ultrasound approach can reduce surgery-related complications, improve patient comfort, and be more cost-effective.

To participate in this trial, women must be over 18 years old and have been diagnosed with certain types of vulvar cancer that are at an early stage (Stage I or II). They should have no signs of cancer spreading beyond the vulva and should be willing to follow the study requirements. Participants will undergo regular ultrasound monitoring instead of surgery and will need to provide written consent to join the study. The trial is not yet recruiting, so more information will be available as it starts. This trial could lead to less invasive treatment options for women facing vulvar cancer.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Females, over 18 years, with histologically confirmed SCC, adenocarcinoma, or melanoma of the vulvar
• • Clinically stage 1 or 2 on medical imaging (CT or MRI scan of pelvis, abdomen, and chest), without evidence of regional or distant metastatic disease
• • Undergo IFL/SNB according to local clinical practice management guidelines
• • Willing and able to comply with all study requirements, timing and/or nature of required assessments.
• • Signed written informed consent
• • Negative (serum or urine) pregnancy (BHCG) test ≤ 30 days of surgery ONLY in pre-menopausal women and women \< 2 years after the onset of menopause.
• Exclusion Criteria:
• • Women with non-invasive vulvar conditions (e.g. non-invasive non-mammary Paget's disease)
• • SCC of the vulvar with depth of invasion ≤1 mm
• • Clinical or medical imaging evidence of regional and/or distant metastatic disease
• • Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator)
• • Other prior malignancies \<5 years before inclusion, except for successfully treated keratinocyte skin cancers, or ductal carcinoma in situ
• • Estimated life expectancy of ≤6 months